Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000424707p
Ethics application status
Submitted, not yet approved
Date submitted
24/02/2022
Date registered
14/03/2022
Date last updated
10/02/2023
Date data sharing statement initially provided
14/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Motor Improvement in Neurological Conditions: Stroke telerehabilitation feasibility study
Scientific title
Motor Improvement in Neurological Conditions: A feasibility study on the effectiveness of an in-patient motor telerehabilitation program for individuals following stroke
Secondary ID [1] 306056 0
Nil
Universal Trial Number (UTN)
U1111-1272-5613
Trial acronym
MINC: Stroke TeleRehab
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 324698 0
Condition category
Condition code
Stroke 322150 322150 0 0
Haemorrhagic
Stroke 322151 322151 0 0
Ischaemic
Physical Medicine / Rehabilitation 322875 322875 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study participants will train for 8 sessions of 45min time on task on a telerehabilitation system (TRCare). The sessions contain upper limb exercises, games and stroke education. Half of the sessions are supervised by a member of the research team. Patients will complete this study whilst being an inpatient. Half of the sessions will be supervised one-on-one either in-person or virtually with a HIPPA compliant video conference software. Half of the sessions will be unsupervised. The research team can monitor online how long patients have been using the system in order to track adherence to the protocol. A therapist will design the treatment schedule online (via the TRCare portal) and revise the schedule after 1 week. The difficulty of the exercises will be set for each patient individually. Difficulty can be changed for example by offering more difficult levels of the games (such as whac-a-mole) on the device, or by using stiffer therabands in the physical exercises. Stroke education will be provided with a set of predetermined multiple choice questions, developed by clinicians working with TRCare.
Intervention code [1] 322461 0
Rehabilitation
Intervention code [2] 323020 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329916 0
Feasibility will be evaluated according to recommendations outlined by Learmonth & Motl (2018), with process, resource, management and scientific metrics examined via an audit of study records retained in the study database. Process: Evaluation of the process metric will involve an audit of participant recruitment and retention data (number referred, number eligible, number enrolled, number of withdrawals, trial recruitment rate, trial completion rate). Resource: Evaluation of the resource metric will involve an audit of communication with participants and staff (the method and time spent communicating with staff and participants will be recorded), as well as all monetary costs involved with execution of the research. Management: Evaluation of the management metric will involve an audit of research ethics and governance approval procedures, staff preparation time for participant communication, time and accuracy in data collection/entry and the reporting and handling of adverse events (AEs; musculoskeletal injury), serious adverse events (SAEs; serious falls) and clinical emergencies (cardiovascular events). Scientific: Evaluation of the scientific metric will involve an audit of AEs, SAEs and clinical emergencies. In addition, it will involve an audit of participant experiences, burden, adherence and compliance to interventions (via an intervention diary and weekly telehealth chats). Participant experiences will be captured with a semi-structured interview and will probe barriers and motivators to engagement and perceived positive and negatives about interventions. Feasibility metrics are considered a composite outcome.
Timepoint [1] 329916 0
Feasibility will be measured throughout the entirety of the trial in accordance with Learmonth and Motl (2018) recommendations.
Secondary outcome [1] 404267 0
Patient perspectives regarding the intervention program, assessed with a semi-structured interview. The interview format was designed for this study. The interviews will be audio recorded and conducted face-to-face or via telecommunication methods.
Timepoint [1] 404267 0
After 8 training sessions.
Secondary outcome [2] 404268 0
Nine hole peg test to assess manual dexterity
Timepoint [2] 404268 0
Visit 1 (basel.ine) and after 8 training sessions.
Secondary outcome [3] 404269 0
Fugle-meyer upper extremity to assess motor recovery.
Timepoint [3] 404269 0
Visit 1 (baseline) and after 8 training sessions.
Secondary outcome [4] 404270 0
Box-and-block test to assess manual dexterity.
Timepoint [4] 404270 0
Visit 1 (baseline) and after 8 training sessions.
Secondary outcome [5] 404271 0
Modified ashworth spasticity scale to assess arm spasticity
Timepoint [5] 404271 0
Visit 1 (baseline) and after 8 training sessions.
Secondary outcome [6] 404272 0
Modified rankin scale to measure the degree of disability after stroke
Timepoint [6] 404272 0
Visit 1(baseline) and after 8 training sessions.
Secondary outcome [7] 404273 0
Stroke knowledge exam (developed by TRCare) to assess knowledge about stroke risk factors and prevention (TRCare based)
Timepoint [7] 404273 0
Visit 1 (baseline) and after 8 training sessions.
Secondary outcome [8] 404274 0
Shoulder abduction finger extension (SAFE) score to assess arm function
Timepoint [8] 404274 0
Visit 1 (baseline) and after 8 training sessions.
Secondary outcome [9] 404276 0
Stroke impact scale 16 (SIS-16)
Timepoint [9] 404276 0
Visit 1 (baseline) and after 8 training sessions.
Secondary outcome [10] 404277 0
EuroQol-5D quality of life measure
Timepoint [10] 404277 0
Visit 1 (baseline) and after 8 training sessions.
Secondary outcome [11] 404278 0
Grip strength assessed with dynamometer
Timepoint [11] 404278 0
Visit 1 (baseline) and after 8 training sessions.
Secondary outcome [12] 404282 0
Patient satisfaction with the telerehab system quesionairre. These are 12 statements where patients will indicate on a 5 point likert scale how much they agree with the question.
Timepoint [12] 404282 0
Week 2 of the training program.
Secondary outcome [13] 406366 0
Arm and shoulder pain (composite measure) assessed with a visual analogue scale (VAS)
Timepoint [13] 406366 0
After each training session
Secondary outcome [14] 406367 0
Fatigue assessed with a visual analogue scale (VAS)
Timepoint [14] 406367 0
After each training session
Secondary outcome [15] 406368 0
Daily motor testing with a game on the TRCare unit (whack-a-mole)
Timepoint [15] 406368 0
At the start of each training session
Secondary outcome [16] 406369 0
Stroke education quiz, completed on TRCare unit
Timepoint [16] 406369 0
Daily in week 1 and 2 of the training program.
Secondary outcome [17] 406791 0
Record amount of rehabilitation therapy received outside of study procedures, this will be completed by participant self-reporting during the supervised training sessions and logged in a patient logbook/demographics form by study personnel.
Timepoint [17] 406791 0
Weekly for the entire duration of the 2-week intervention.
Secondary outcome [18] 415730 0
Stroke specific Quality of Life scale
Timepoint [18] 415730 0
Visit 1 (baseline) and Visit 2 after the 8 training sessions.
Secondary outcome [19] 415731 0
Therapist's perspectives regarding the intervention program, assessed with a semi-structured interview. The interview format was designed for this study. The interviews will be audio recorded and conducted face-to-face or via telecommunication methods.
Timepoint [19] 415731 0
Upon study completion.
Secondary outcome [20] 415732 0
Study staff's perspectives regarding the intervention program, assessed with a semi-structured interview. The interview format was designed for this study. The interviews will be audio recorded and conducted face-to-face or via telecommunication methods.
Timepoint [20] 415732 0
Upon study completion.
Secondary outcome [21] 415733 0
Montreal Cognitive Assessment (Moca), a cognitive screening tool.
Timepoint [21] 415733 0
At visit 1 (baseline) and after 8 training sessions.

Eligibility
Key inclusion criteria
1. Age 18 years or older

2. Stroke that has been radiologically verified

3. Arm motor FM score <56 (out of 66) at Visit 1

4. Box & Block Test score with affected arm is at least 3 blocks in 60 seconds at Visit 1

5. Informed consent signed by the subject

6. Admitted to Osborne Park Hospital for stroke rehabilitation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. A major, active, coexistent neurological or psychiatric disease, e.g., alcohol dependency or dementia
2. A major medical disorder that substantially reduces the likelihood that a participant will be able to comply with all study procedures
3. Significant cognitive impairment, defined as Montreal Cognitive Assessment score < 22 (a lower score is permitted if due to aphasia and if the patient is specifically allowed by study PI))
4. Deficits in communication that interfere with reasonable study participation
5. Lacking visual acuity, with or without corrective lens, of 20/40 or better in at least one eye
6. Life expectancy < 6 months
7. Pregnant
8. Receipt of Botox to arms, legs, or trunk in the preceding 6 months, or expectation that Botox will be administered to the arm, leg, or trunk within 3 months of study enrolment
9. Unable to successfully perform all 3 of the rehabilitation exercise test examples
10. Unable or unwilling to perform study procedures/therapy or attend study visits, or expectation of noncompliance with study procedures/therapy
11. Does not speak sufficient English to comply with study procedures

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Appropriate statistics will be used to analyse the qualitative and quantitative data. Data Analysis will be performed with statistical software (like SPSS), levels of significance will be set at P < 0.05. If necessary, a Bonferroni correction for multiple comparisons will be applied. There will be no interim analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/02/2023
Actual
Date of last participant enrolment
Anticipated
25/12/2023
Actual
Date of last data collection
Anticipated
8/01/2024
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 21343 0
Osborne Park Hospital - Stirling
Recruitment postcode(s) [1] 36234 0
6021 - Stirling

Funding & Sponsors
Funding source category [1] 310394 0
University
Name [1] 310394 0
Edith Cowan University
Country [1] 310394 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup drive
6027, Joondalup, WA
Australia
Country
Australia
Secondary sponsor category [1] 311545 0
None
Name [1] 311545 0
Address [1] 311545 0
Country [1] 311545 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310043 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 310043 0
Ethics committee country [1] 310043 0
Australia
Date submitted for ethics approval [1] 310043 0
03/11/2021
Approval date [1] 310043 0
Ethics approval number [1] 310043 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116290 0
Prof Dylan Edwards
Address 116290 0
Edith Cowan University, SMHS
270 Joondalup drive
6027, Joondalup WA
Country 116290 0
Australia
Phone 116290 0
+61 863043624
Fax 116290 0
Email 116290 0
[email protected]
Contact person for public queries
Name 116291 0
Kirsten van Rijn
Address 116291 0
Edith Cowan University, SMHS
270 Joondalup drive
6027, Joondalup WA
Country 116291 0
Australia
Phone 116291 0
+61 863046977
Fax 116291 0
Email 116291 0
[email protected]
Contact person for scientific queries
Name 116292 0
Onno van der Groen
Address 116292 0
Edith Cowan University, SMHS
270 Joondalup drive
6027, Joondalup WA
Country 116292 0
Australia
Phone 116292 0
+61 863043644
Fax 116292 0
Email 116292 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is an early-stage feasibility trial, therefore IPD will not be available at this stage.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.